Q2 2025 Innate Pharma SA Earnings and Business Update Call
Speaker #3: Thank you for standing by, and welcome to the Innate Pharma first half 2025 business update and financial results conference call. All lines have been placed on mute to prevent any background noise.
Speaker #3: After the speakers' remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad.
Speaker #3: If you would like to withdraw your question, again press *1. Thank you. I would now like to turn the call over to Stephanie Cornin, Vice President of Investor Relations and Communications. You may begin.
Operator: I'd now like to turn the call over to Stéphanie Cornen, Vice President, Investor Relations and Communications. You may begin.
Speaker #1: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's H1 2025 business update and financial results conference call. The press release and today's presentation are both available on the IR section of our website.
Stéphanie Cornen: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma H1 2025 Business Update and Financial Results Conference call. The press release and today's presentation are both available on the investor section of our website. Before we begin, I'd like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially. I'll briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic overview, fast forward, and commercial opportunity. Our COO, Yannis Morel, will provide an update on the scientific differentiation of our lead ADC. He will then hand over to our CMO, Sonia Quaratino, who will present clinical pipeline updates on IPH4502, lacutamab, and monalizumab. Afterward, our CFO, Frederic Lombard, will review the financials. Jonathan will return with closing remarks and will open the call for Q&A.
Speaker #1: Before we begin, I'd like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially.
Speaker #1: I'll briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic overview, fast forward, and commercial opportunity. Our COO, Yannis Morel, will provide an update on the scientific differentiation of our lead ADC.
Speaker #1: He will then hand over to our CMO, Sonia Quaratino, who will present clinical pipeline updates on IPH45O2, Lacutamab, and Monalizumab. Afterward, our CFO, Frederic Lombard, will review the financials.
Speaker #1: Then, Jonathan will return with closing remarks and will open the call for Q&A. With that, I'll now hand it over to Jonathan.
Stéphanie Cornen: With that, I'll now hand it over to Jonathan.
Speaker #4: Thank you, Stephanie, and good morning to those joining from the U.S. and good afternoon to our participants in Europe. Moving to slide five, Innate Pharma's foundation is in leveraging our deep scientific expertise to advance life-enhancing cancer therapies.
Jonathan Dickinson: Thank you, Stéphanie, and good morning to those joining from the U.S. and good afternoon to our participants in Europe. Moving to slide five, Innate Pharma's foundation is in leveraging our deep scientific expertise to advance life-enhancing cancer therapies. Through our years of pioneering work in antibody engineering, we have built a differentiated, high-value clinical pipeline supported by compelling data, and this positions us to deliver truly transformative treatments. Turning to slide six, during the first half of the year, we've made significant progress across our portfolio, and today marks an important new chapter for Innate Pharma. As you may have read in the press release for our half-yearly update that we issued earlier today, we have made the strategic decision to focus our investment where we believe we can deliver the greatest impact for both patients and our shareholders.
Speaker #4: Through our years of pioneering work in antibody engineering, we have built a differentiated, high-value clinical pipeline supported by compelling data, and this positions us to deliver truly transformative treatments.
Speaker #4: Turning to slide six, during the first half of the year, we've made significant progress across our portfolio. Today marks an important new chapter for Innate.
Speaker #4: As you may have read in the press release for our half-yearly update that we issued earlier today, we have made the strategic decision to focus our investment where we believe we can deliver the greatest impact.
Speaker #4: For both patients and our shareholders, therefore, going forward, our main investments will be centered on three high-value clinical assets: IPH45O2, Lacutamab, and Monalizumab. These programs represent the strongest opportunities to transform care and create meaningful value.
Jonathan Dickinson: Therefore, going forward, our main investments will be centered on three high-value clinical assets: IPH4502, lacutamab, and monalizumab. These programs represent the strongest opportunities to transform care and create meaningful value, and they will form the focus of today's discussion. At the same time, we will concentrate on selecting and advancing our next ADCs towards clinical development. As a consequence of this prioritization and sharpened focus, we intend to streamline our organization to deliver on our strategic objectives and key near-term milestones. This is a pivotal moment for Innate Pharma. We are aligning our strategy, our science, our organization, and our investments to drive forward the programs that can truly make the biggest difference. I could not be more confident in the path we are taking, and I'm excited to share with you how we will execute on this vision in the coming presentation.
Speaker #4: And they will form the focus of today's discussion. At the same time, we will concentrate on selecting and advancing our next ADCs towards clinical development.
Speaker #4: As a consequence of this prioritization and sharpened focus, we intend to streamline our organization to deliver on our strategic objectives and key near-term milestones.
Speaker #4: This is a pivotal moment for Innate. We are aligning our strategy, our science, our organization, and our investments to drive forward the programs that can truly make the biggest difference.
Speaker #4: I could not be more confident in the path we are taking, and I'm excited to share with you how we will execute on this vision in the coming presentation.
Speaker #4: As you will also have seen in this morning's announcement, our CSO, Eric Vivier, has decided to return to full-time academic research. Eric has been a true driver of the scientific agenda within Innate.
Jonathan Dickinson: As you will also have seen in this morning's announcement, our Chief Scientific Officer, Eric Vivier, has decided to return to full-time academic research. Eric has been a true driver of the scientific agenda within Innate Pharma, so we are extremely pleased that he will continue to support the company's innovation in the important role as an advisor to the R&D Committee of the Board of Directors. Our Chief Operating Officer, Yannis Morel, has always had responsibilities for preclinical research and development, and he will now also assume the Chief Scientific Officer responsibilities. With that, I will now hand it over to Yannis for a closer look at our lead ADCs and the potential. Yannis.
Speaker #4: So we are extremely pleased that he will continue to support the company's innovation in the important role as an advisor to the R&D Committee of the Board of Directors.
Speaker #4: Our Chief Operating Officer, Yannis Morel, has always had responsibilities for preclinical research and development, and he will now also assume the Chief Scientific Officer responsibilities.
Speaker #4: With that, I will now hand it over to Yannis for a closer look at our lead ADCs and their potential. Yannis.
Yannis Morel: Thank you, Jonathan. First, on slide eight, let me share with you why we think NECTIN-4 is an attractive target for our next-generation ADC and why our highly differentiated NECTIN-4 ADC has broad potential across many solid tumors. Even though NECTIN-4 is a validated ADC target, enfortumab vedotin carries some challenges and has several limitations. It is approved solely for patients with urothelial cancer where NECTIN-4 expression is the highest. In addition, enfortumab vedotin-related toxicity often leads to treatment discontinuation, and relapses are frequently observed, creating a growing medical need in the post-enfortumab vedotin setting. Finally, even though NECTIN-4 is expressed at moderate to high level in several other tumor types, there is limited evidence showing that enfortumab vedotin is active beyond urothelial cancer. On the next slide, slide nine, I want to show you why we are so excited by our next-generation NECTIN-4 ADC program called IPH4502.
Speaker #4: First, on slide eight, let me share with you why we think NextInfo is an attractive target for our next-generation ADC and why our highly differentiated NextInfo ADC has potential across many solid tumors.
Speaker #4: Even though NextInfo is a validated ADC target, our unfortunate battle team carries some challenges and has several limitations. It is a proven solution for patients with erythrematic cancer, where NextInfo expression is the highest.
Speaker #4: In addition, that said, related toxicity often leads to treatment discontinuations, and relapses are frequently observed, creating a growing medical need in the post-PADCEF setting.
Speaker #4: Finally, even though NextInfo is expressed at a moderate to high level in several other tumor types, there is limited evidence showing that PADCEF is active beyond erythematic cancer.
Speaker #4: On the next slide, slide nine, I want to show you why we are so excited about our next-generation NextInfo ADC program called IPH45O2. As I said previously, this is a differentiated ADC that leverages a novel design to improve both safety and efficacy.
Yannis Morel: As I said previously, this is a differentiated ADC that leverages a novel design to improve both safety and efficacy. IPH4502 is based on a proprietary humanized antibody that binds a unique epitope on the NECTIN-4 molecule. The linker used is stable, cleavable, and hydrophilic, ensuring high ADC exposure and low systemic release of free exatecan, which minimizes potential side effects. The payload itself, exatecan, is a potent topoisomerase-1 inhibitor. It shows what's called bystander activity, which means it impacts neighboring tumor cells that do not express high levels of NECTIN-4 and can therefore address tumors with heterogeneous expression of NECTIN-4. In addition, it remains highly active in enfortumab vedotin or MMAE resistance models, allowing it to target tumors that have or became resistant to EV. In summary, the design of IPH4502 is purpose-built to overcome the limitations seen with existing therapies such as enfortumab vedotin.
Speaker #4: IPH45O2 is based on a proprietary humanized antibody that binds a unique epitope on the NextInfo molecule. The linker used is stable, cleavable, and hydrophilic, ensuring high adhesive exposure and low systemic release of free exatican, which minimizes potential side effects.
Speaker #4: The payload itself, Exatican, is a potent topoisomerase-1 inhibitor. It shows what's called bystander activity, which means its impacts neighboring tumor cells that do not express a high level of NextInfo, and can therefore address tumors with heterogeneous expression of NextInfo.
Speaker #4: In addition, it remains highly active in unfortunate battle team or MME resistance models, allowing it to target tumors that are or have become resistant to ED.
Speaker #4: In summary, the design of IPH45O2 is purpose-built to overcome the limitations seen with existing therapies, such as unfortunate battle team. On the next slide, slide 10, turning to preclinical data, we were also pleased to present at the AACR Annual Meeting our findings that highlight the differentiated potential of IPH45O2.
Yannis Morel: On the next slide, slide 10, turning to preclinical data, during the period, we were also pleased to present at the AACR annual meeting our findings that highlight the differentiated potential of IPH4502. Starting from a PDX model of urothelial cancer, we generated a model of acquired resistance by exposing tumors to repeated cycles of enfortumab vedotin. As anticipated, tumors that were initially sensitive became resistant to EV while keeping expression of NECTIN-4. What is remarkable is that in the same model, IPH4502 maintained its activity. While enfortumab vedotin lost efficacy, IPH4502 continued to control tumor growth, underscoring its differentiated profile and the opportunity to address patients who no longer respond to enfortumab vedotin. On the next slide, slide 11, our preclinical data also demonstrated anti-tumor activity in PDX models with low or heterogeneous NECTIN-4 expression from various tumor types, including, for example, triple-negative breast, esophageal, and NMN cancer.
Speaker #4: Starting from a PDX model of erythematic cancer, we generated a model of acquired resistance by exposing tumors to repeated cycles of unfortunate battle team.
Speaker #4: As anticipated, tumors that were initially sensitive became resistant to ED while maintaining expression of NextInfo. But what is remarkable is that in the same model, IPH45O2 maintains its activity.
Speaker #4: While ED lost efficacy, IPH45O2 continued to control tumor growth, underscoring its differentiated profile and the opportunity to address patients who no longer respond to ED.
Speaker #4: On the next slide, slide 11, our preclinical data also demonstrated anti-tumor activity in PDX model with low or heterogeneous NextInfo expression. From various tumor types, including for example, triple-negative breast, esophageal, and neck cancer.
Speaker #4: These results highlight the potential of IPH45O2 to extend the reach of NextInfo targeting beyond erythematic cancer into tumor types with significant medical needs. IPH45O2 is currently in phase one development, and we are very excited about the potential of this novel and differentiated NextInfo exatican ADC to address high unmet medical needs, both in bladder cancer post-ED, but also in solid tumors with low or heterogeneous expression of NextInfo.
Yannis Morel: These results highlight the potential of IPH4502 to extend the reach of NECTIN-4 targeting beyond urothelial cancer into tumor types with significant medical needs. IPH4502 is currently in phase 1 development, and we are very excited about the potential of this novel and differentiated NECTIN-4 antibody-drug conjugate to address high unmet medical needs, both in bladder cancer post enfortumab vedotin, but also in solid tumors with low or heterogeneous expression of NECTIN-4, representing a potentially broad market opportunity. I will now hand over to Sonia, who will discuss the clinical progress of IPH4502, as well as our other clinical programs.
Speaker #4: This presenting a potentially broad market opportunity. I'll now hand over to Sonia Quaratino, who will discuss the clinical progress of IPH45O2 as well as our other clinical programs.
Speaker #1: Thank you, Yannis. Today, I will focus on preclinical assets that represent the potential to create the highest value for Innate: IPH45O2, Lacutamab, and Monalizumab.
Sonia Quaratino: Thank you, Yannis. Today, I will focus on three clinical assets that represent the potential to create the highest value for Innate Pharma: IPH4502, lacutamab, and monalizumab. In the next slide, starting with IPH4502, the ADC directed against NECTIN-4, this is a trial that is an asset that is currently investigated in a first-in-human phase 1 study. Enrollment in this dose escalation is going very well, and we are now on track to complete enrollment before the end of Q1 2026. The objective of the study is to assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express NECTIN-4. We are pleased to present this study in a trial-in-progress poster at ASCO annual meeting in Chicago. The dose escalation is guided by an adaptive Bayesian design to determine the maximum tolerated dose.
Speaker #1: In the next slide, starting with IPH45O2, the ADC directed against NextInfo, this is a trial that is currently being investigated in a first-in-human phase one study.
Speaker #1: Enrollment in this dose escalation is going very well, and we are now on track to complete enrollment before the end of Q1 2026. The objective of the study is to assess the safety, tolerability, and preliminary efficacy of IPH45O2 in advanced solid tumors known to express NextInfo.
Speaker #1: And we are pleased to present this study in a trial-in-progress poster at the ASCO Annual Meeting in Chicago last June. The dose escalation is guided by an adaptive design to determine the maximum tolerated dose.
Speaker #1: And once this is established, patients in one or two selected indications will be randomized across two dose levels to define the recommended Phase 2 dose, as per FDA guidelines.
Sonia Quaratino: Once this is established, patients in one or two selected indications will be randomized across two dose levels to define the recommended phase 2 dose as per FDA guidelines. The anti-tumor activity of IPH4502 as a single agent will be further explored at RP2D in an expansion phase in selected indications in which signs of activity have been detected in the dose escalation. As well as confirming that the drug has a favorable safety profile and tolerability, the goal of this phase 1 trial is to generate efficacy data that will guide the path forward for IPH4502, such as a basket trial in combination with standard of care or expansion phase to help maximize its value for both patients and shareholders. In slide 14, we have the key milestones ahead for IPH4502.
Speaker #1: The anti-tumor activity of IPH45 as a single agent will be further explored at RP2D in an expansion phase in selected indications in which signs of activity have been detected in the dose escalation.
Speaker #1: As well as confirming that the drug has a favorable safety profile and tolerability, the goal of this Phase One trial is to generate efficacy data that will guide the path forward for IPH4502.
Speaker #1: Such as a basket trial in combination with standard of care, or an expansion phase, to help maximize its value for both patients and shareholders. In Slide 14, we have the key milestones ahead for IPH4502.
Speaker #1: With enrollment progressing well, we expect to report preliminary safety and activity data in the first half of 2026. The preclinical data presented earlier by Yannis Morel are guiding us towards two key hypotheses to be explored in the clinic.
Sonia Quaratino: With enrollment progressing well, we expect to report preliminary safety and activity data in the first half of 2026. The preclinical data presented earlier by Yannis are guiding us towards two key hypotheses to be explored in the clinic. The first, it's in urothelial carcinoma in the post-EV setting where IPH4502 may overcome resistance to EV. This represents an area of high unmet need with no approved drugs and the potential to move rapidly into late-stage development is large. The second is to look for signals in other tumor types where NECTIN-4 expression may be low or heterogeneous, which could open an even broader opportunity. With this hypothesis, the clinical data will guide us towards the indication where IPH4502 can make the greatest impact. Now, turning on next slide on lacutamab, we are close to completion of the phase 3 protocol following alignment with the FDA and EMA.
Speaker #1: The first is an erythematous carcinoma in the post-ED setting, where IPH45O2 may overcome resistance to ED. This represents an area of high unmet need, with no approved drugs, and the potential to move rapidly into late-stage development is large.
Speaker #1: The second is to look for signals in other tumor types, where NextInfo expression may be low or heterogeneous. This could open an even broader opportunity.
Speaker #1: This hypothesis, the clinical data will guide us towards the indication where IPH4502 can make the greatest impact. Now, turning to the next slide on Lacutamab, we are close to completion of the phase three protocol following alignment with the FDA and EMA.
Speaker #1: To recap, Lacutamab is a first-in-class anti-TIE2 antibody in development for the treatment of cutaneous tissue lymphoma and peripheral tissue lymphoma. In cutaneous T-cell lymphoma (CTTL), Lacutamab has already generated strong long-term follow-up data, which we presented at ASCO earlier this year and which we will summarize in the next slide.
Sonia Quaratino: To recap, lacutamab is a first-in-class anti-KIR3DL2 antibody in development for the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma. In CTCL, lacutamab has already generated strong long-term follow-up data, which we presented at ASCO this year and which we'll summarize in the next slide. Importantly, the regulatory pathway is clear, supported by key designations that position lacutamab for potential accelerated approval in Sézary syndrome. Our confidence in the program was further strengthened earlier this year when the FDA granted breakthrough therapy designation for relapsed or refractory Sézary syndrome based on the TelomAK phase 2 results. This designation is intended to accelerate both development and regulatory review of drugs that address serious conditions. Beyond CTCL, PTCL, peripheral T-cell lymphoma represents a second indication. It's a group of aggressive lymphomas with poor prognosis and a significant life cycle management opportunity for lacutamab.
Speaker #1: Importantly, the regulatory pathway is clear, supported by key designations that position Lacutamab for potential accelerated approval in cellular syndrome. Our confidence in the program was further strengthened earlier this year when the FDA granted breakthrough therapy designation for relapsed or refractory cellular syndrome based on the Telomere Phase Two results.
Speaker #1: This designation is intended to accelerate both development and regulatory review of drugs that address serious conditions. Beyond CTTL, PTCL, or peripheral tissue lymphoma, represents a second indication; it's a group of aggressive lymphomas with poor prognosis and the significant life cycle management opportunity for Lacutamab.
Speaker #1: Importantly, here, trivial correlates with worse clinical outcomes and is expressed in approximately 40% of PTCL patients. In PTCL, Lacutamab has previously demonstrated some objective responses as a single agent, reinforcing the relevance of the target and providing the rationale to pursue development in combination with chemotherapy.
Sonia Quaratino: Importantly, KIR3DL2 correlates with worse clinical outcomes, and this is expressed in approximately 40% of PTCL patients. In PTCL, lacutamab has previously demonstrated some objective responses as a single agent, reinforcing the relevance of the target and providing the rationale to pursue development in combination with chemotherapy. Building on these findings, lacutamab is now being investigated in the TILT trial, a randomized phase 2 in combination with gemcitabine and oxaliplatin versus gemcitabine and oxaliplatin in relapsed refractory KIR3DL2 positive PTCL patients. When we move to the next slide and to recap the data in CTCL that we presented at ASCO 2025, the long-term follow-up data from the TelomAK phase 2 trial, here we see the results in Sézary syndrome, which is an aggressive subtype of PTCL, and post-mogamulizumab, where there are no approved drugs, we have shown clinical efficacy.
Speaker #1: Building on these findings, Lacutamab is now being investigated in the QILT trial, a randomized phase 2 trial in combination with gemcitabine and oxaliplatin, versus gemcitabine and oxaliplatin in relapsed refractory PTCL patients who are tumor positive.
Speaker #1: When we move to the next slide, and to recap the data in CTTL that we presented at ASCO 2025, the long-term follow-up data from the Telomere Phase Two trial. Here we see the results in cellular syndrome, which is an aggressive subtype of CTTL, and post-mogamulizumab, where there are no approved drugs. We had shown clinical efficacy.
Speaker #1: In heavily pretreated patients, all pretreated with MOGA, Lacutamab demonstrated a global overall response rate of 42 point nine percent. And the median progression pre-survival of eight point three months.
Sonia Quaratino: In heavily pretreated patients, all pretreated with MOGA, lacutamab demonstrated a global overall response rate of 42.9% and a median progression-free survival of 8.3 months. Of note, the median duration of response was 25.6 months, underscoring lacutamab's potential to deliver durable clinical benefit in this very aggressive and difficult-to-treat population. Turning in the next slide to mycosis fungoides, the long-term follow-up data from the TelomAK phase 2 trial showed that lacutamab achieved a global overall response rate of 19.6%, with consistent activity observed regardless of KIR3DL2 expression level. The median duration of response was 13.8 months, and median progression-free survival was 10.2 months, with no difference between the two subgroups. Importantly, in both Sézary syndrome and mycosis fungoides, every patient who achieved a complete response remained in response at the time of the data cutoff, once again highlighting lacutamab's ability to deliver durable benefit even in heavily pretreated patients.
Speaker #1: Of note, the median duration of response was 25.6 months, scoring Lacutamab’s potential to deliver durable clinical benefit in this very aggressive and difficult-to-treat population.
Speaker #1: Turning to my causes for goiters, the long-term follow-up data from the telomere phase two trial showed that Lacutamab achieved a global overall response rate of 19.6%, with consistent activity observed regardless of the trivial to expression level.
Speaker #1: The median duration of response was 13.8 months, and the median progression-free survival was 10.2 months, with no difference between the two subgroups. Importantly, in both cellular syndrome and my causes for goiters, every patient who achieved a complete response remained in response at the time of the data cut-off. This once again highlights Lacutamab's ability to deliver durable benefit even in heavily pretreated patients.
Speaker #1: In both indications, cellular and my causes for goiters, Lacutamab was well tolerated, with an excellent safety profile that supports its potential use for long systemic therapy.
Sonia Quaratino: In both indications, Sézary and mycosis fungoides, lacutamab was well tolerated with an excellent safety profile that supports its potential use for long systemic therapy. Now, in the next slide, let's look at the potential positioning of lacutamab in CTCL. The challenges in CTCL care are well known. The disease has a profound impact on quality of life, with patients suffering from itching, fatigue, and cutaneous lesions, with important psychosocial implications. Preventing progression to advanced stages is critical, as outcomes in stage 2B and beyond are poor. Yet, very few tolerable systemic options are currently available for early-stage patients. This is where lacutamab can make a real difference. Our data have shown deep anti-tumor activity, durable responses, and meaningful progression-free survival. Equally important, lacutamab has shown an excellent safety profile, overcoming the tolerability concern of other systemic therapies in earlier stages of disease.
Speaker #1: Now, in the next slide, let's look at the potential positioning of Lacutamab in CTTL. The challenges in CTTL care are well known; the disease has a profound impact on quality of life, with patients suffering from itching, fatigue, and cutaneous lesions.
Speaker #1: With important psychosocial implications, preventing progression to advanced stages is critical, as outcomes in stage 2B and beyond are poor. Yet, very few tolerable systemic options are currently available for early-stage patients.
Speaker #1: And this is where Lacutamab can make a real difference. Our data have shown deep anti-tumor activity, durable responses, and meaningful progression-free survival. Equally important, Lacutamab has shown an excellent safety profile, overcoming the tolerability concerns of other systemic therapies in earlier stages of disease.
Speaker #1: Furthermore, Lacutamab addressed the symptoms that matter most to patients, with a positive impact on their quality of life. In the next slide, we see that the combination of strong efficacy with excellent safety makes Lacutamab a unique candidate for the earlier use of systemic therapy in CTTL.
Sonia Quaratino: Furthermore, lacutamab addresses the symptoms that matter most to patients, with a positive impact on their quality of life. In the next slide, we see that the combination of strong efficacy with excellent safety makes lacutamab a unique candidate for earlier use of systemic therapy in CTCL. This becomes particularly important in mycosis fungoides, where survival estimates deteriorate once patients progress to more advanced stages. As you can see, in stage 2B and beyond, the five-year survival is lower than 50%. Poor survival in late-stage MF highlights the need for systemic therapies that can be used earlier to change the course of the disease. Here is where lacutamab could fill a critical gap, offering a tolerable systemic option that can be introduced at an earlier time point, with the potential to delay progression and improve patient outcomes.
Speaker #1: And this becomes particularly important in my causes for goiters, where survival estimates deteriorate once patients progress to more advanced stages, as you can see in stage 2B and beyond.
Speaker #1: The five-year survival rate is lower than 50%. Poor survival in late-stage MF highlights the need for systemic therapies that can be used earlier to change the course of the disease.
Speaker #1: And here is where Lacutamab could fill a critical gap, offering a tolerable systemic option that can be introduced at an earlier time point, with the potential to delay progression and improve patient outcomes.
Speaker #1: So, altogether, we are on track to advance Lacutamab towards Phase 3 in CTTL. As discussed, we are close to finalizing the Phase 3 protocol following interactions with the FDA and EMA.
Sonia Quaratino: Altogether, we are on track to advance lacutamab towards phase 3 in cutaneous T-cell lymphoma. As discussed, we are close to finalizing the phase 3 protocol following interaction with the FDA and EMA. Once financing is secure, we will be positioned to initiate the confirmatory phase 3 trial next year, with the potential for accelerated approval the following year as enrollment advances in Sézary syndrome, targeting approximately 2027. The key next step will be to determine the optimal path forward, whether through partnering or additional investor support, always with the goal of maximizing value for both patients and shareholders. In parallel, in peripheral T-cell lymphoma, the Liza-sponsored TILT trial continues to enroll patients. We look forward to data from this study in 2026, which could further validate lacutamab's potential across additional T-cell lymphoma.
Speaker #1: And once financing is secure, we will be positioned to initiate the confirmatory Phase 3 trial next year, with the potential for accelerated approval the following year as enrollment advances in cellular syndrome.
Speaker #1: Targeting approximately 2027, the key next step will be to determine the optimal path forward, whether through partnering or additional investor support, always with the goal of maximizing value for both patients and shareholders.
Speaker #1: In parallel, in PTCL, the light of the sponsored QILT trial continues to enroll patients. We look forward to data from this study in 2026, which could further validate Lacutamab's potential across additional T-cell lymphoma.
Speaker #1: Now, switching gears, in the next slide, we discuss another late-stage program, Monalizumab, with great potential value creation for the company. As a reminder, Monalizumab is the first-in-class anti-angiogenic 2A checkpoint inhibitor currently evaluated in a Phase 3 clinical trial in lung cancer, by our partner AstraZeneca, in combination with Durvalumab.
Sonia Quaratino: Switching gears, in the next slide, we discuss another late-stage program, monalizumab, with great potential value creation for the company. As a reminder, monalizumab is a first-in-class anti-NKG2A checkpoint inhibitor currently evaluated in a phase 3 clinical trial in lung cancer by our partner AstraZeneca, in combination with durvalumab. Three phase 2 trials, NEO/COST and NEO/COST-2, demonstrated a strong rationale for this combination in unresectable non-small cell lung cancer and in the neoadjuvant setting. The phase 3 PACIFIC-9 trial aims to demonstrate efficacy of durvalumab in combination with either monalizumab or the AstraZeneca anti-CD73 antibody or leflunomab in patients with unresectable stage 3 non-small cell lung cancer who have not progressed following classic platinum-based concurrent chemoradiation therapy. The study is now fully recruited, and it remains on track for primary completion at the end of the first half of 2026.
Speaker #1: The three-phase two trial cost, now cost, and now cost two, demonstrated a strong rationale for this combination in unresectable non-small cell lung cancer, and in the neoadjuvant setting.
Speaker #1: Now, the Phase 3 specific nine trial aims to demonstrate the efficacy of Durvalumab in combination with either Monalizumab or the AstraZeneca anti-CD73 antibody, Oleclumab, in patients with unresectable stage three non-small cell lung cancer, who have not progressed following classic platinum-based concurrent chemoradiation therapy.
Speaker #1: The study is now fully recruited and remains on track for primary completion at the end of the first half of 2026. This is an important catalyst for the program, with data expected in the second half of 2026.
Sonia Quaratino: This is an important catalyst for the program, with data expected in the second half of 2026. I am going to hand over to Jonathan again, who will walk through the commercial opportunity of these two late-stage assets, lacutamab and monalizumab.
Speaker #1: Now, I'm going to hand over to Jonathan again, who will walk through the commercial opportunity of these two late-stage assets, Lacutamab and Monalizumab.
Speaker #4: Thank you, Sonia, for showing how Lacutamab has the potential to fundamentally reshape the care of CTTL patients. As you can see on slide 23, the opportunity for Lacutamab starts with cellular syndrome, where following a potential accelerated approval in 2027, we see a clear launch pathway.
Jonathan Dickinson: Thank you, Sonia, for showing how lacutamab has the potential to fundamentally reshape the care of CTCL patients. As you can see on slide 23, the opportunity for lacutamab starts with Sézary syndrome, where following a potential accelerated approval in 2027, we see a clear launch pathway. In the past months, by assessing U.S. claims data, we have identified a significantly greater opportunity in Sézary syndrome than previously anticipated. It's been established that there are around 1,000 Sézary syndrome patients in the U.S., with approximately 300 new cases each year and a large pool of post-mogamulizumab-treated patients. This represents a meaningful and de-risked first market opportunity for lacutamab following an accelerated approval.
Speaker #4: In the past months, by assessing U.S. claims data, we have identified a significantly greater opportunity in cellular syndrome than previously anticipated. It's been established that there are around 1,000 cellular syndrome patients in the U.S., with approximately 300 new cases each year and a large pool of post-mogamolizumab-treated patients.
Speaker #4: This represents a meaningful and de-risked first market opportunity for Lacutamab following an accelerated approval. After accelerated approval in cellular syndrome, the opportunity expands into second-line plus settings for my causes for goiters and ultimately into earlier stages of CTTL patients, where a tolerable systemic option is currently lacking and where Lacutamab has the potential to create a new market opportunity and change the course of the disease for patients through early intervention to stop or delay disease progression beyond stage 2A.
Jonathan Dickinson: After accelerated approval in Sézary syndrome, the opportunity expands into second-line plus setting for mycosis fungoides and ultimately into earlier stages of CTCL patients where a tolerable systemic option is currently lacking and where lacutamab has the potential to create a new market opportunity and change the course of the disease for patients through early intervention to stop or delay disease progression beyond stage 2A. It's been established through the same U.S. claims data that there are approximately 20,000 CTCL patients in the U.S., with an incidence of approximately 5,000 patients, suggesting a larger population than previously estimated based on publicly available data. These new dynamics, combined with the additional potential in PTCL, have led us to reconsider our strategy and the value we assign to lacutamab.
Speaker #4: It's been established through the same U.S. claims data that there are approximately 20,000 CTTL patients in the U.S., with an incidence of approximately 5,000 patients, suggesting a larger population than previously estimated based on publicly available data.
Speaker #4: These new dynamics, combined with the additional potential in PTCL, have led us to reconsider our strategy and the value we assign to Lacutamab. To maximize the opportunity for Lacutamab, we are currently planning to bring the product into Phase Three and submit a BLA in cellular syndrome, either with the support of investors or with a partner, but with improved deal terms.
Jonathan Dickinson: To maximize the opportunity for lacutamab, we are currently planning to bring the product into phase 3 and submit a BLA in Sézary syndrome, either with the support of investors or with a partner, but with improved deal terms. Already at launch, lacutamab has the potential to reach a substantial patient population, making it an interesting, profitable, and value-creating opportunity for Innate Pharma. We are actively collecting additional CTCL market data and conducting further analyses, leveraging claims data and market research to further define the market opportunity. We plan to share the new data and market insights at a lacutamab-focused investor event by the end of the year. Turning now to slide 24 and to monalizumab, our partnership with AstraZeneca for monalizumab continues to represent a significant value driver for Innate.
Speaker #4: Already at launch, Lacutamab has the potential to reach a substantial patient population, making it an interesting, profitable, and value-creating opportunity for Innate Pharma.
Speaker #4: We are actively collecting additional CTTL market data and conducting further analyses leveraging claims data and market research to further define the market opportunity. We plan to share the new data and market insights at a Lacutamab-focused investor event by the end of the year.
Speaker #4: Turning now to slide 24 and to Monalizumab, our partnership with AstraZeneca for Monalizumab continues to represent a significant value driver for Innate. The total agreement is worth up to $1.275 billion, and we have already received $450 million in upfront and milestone payments to date under this partnership.
Jonathan Dickinson: The total agreement is worth up to $1.275 billion, and we have already received $450 million in upfront and milestone payments to date under this partnership. Moving forward, Innate is eligible for up to an additional $825 million in development and commercial milestones. Outside of Europe, AstraZeneca records all sales, and Innate will receive double-digit royalties upon commercialization. In Europe, we retain co-formation rights along with a 50% profit share while contributing to a portion of the phase 3 costs with a predefined cap. This structure ensures that Innate remains well positioned to benefit from monalizumab's future success globally. That concludes the pipeline update for this presentation. I will now turn the floor to Frederic Lombard, our Chief Financial Officer, to discuss the financials for the first half of the year. Frederic.
Speaker #4: Moving forward, Innate is eligible for up to an additional $825 million in development and commercial milestones. Outside of Europe, AstraZeneca requires all sales, and Innate will receive double-digit royalties upon commercialization.
Speaker #4: In Europe, we retain co-formation rights, along with a 50% profit share while contributing to a portion of the phase three costs with a predefined cap.
Speaker #4: This structure ensures that Innate remains well-positioned to benefit from Monalizumab's future success globally. That concludes the pipeline update for this presentation. I will now turn the floor to Frederic Lombard, our Chief Financial Officer, to discuss the financials for the first half of the year.
Speaker #4: Frederic.
Speaker #5: Thank you, Jonathan. So for the first half of 2025, we reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi.
Frederic Lombard: Thank you, Jonathan. For the first half of 2025, we've reported a total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca, Sanofi, as well as governmental funding for research expenditures. Operating expenses were reaching $30.3 million, with $20.5 million in R&D and $9.8 million in G&A expenses. R&D expenses decreased by 29% compared to the prior year, reflecting the phasing of certain clinical programs, while G&A expenses remained stable at $9.8 million. At June 30, 2025, we had $70.4 million in cash, cash equivalent, and financial assets, providing a cash runway until the end of the first quarter of 2026. With that, I'm turning it back to Jonathan for closing remarks.
Speaker #5: As well as governmental funding for research expenditures, operating expenses were reaching $30.3 million, with $20.5 million in R&D and $9.8 million in G&A expenses.
Speaker #5: R&D expenses decreased by 29% compared to the prior year, reflecting the phasing of certain clinical programs. While G&A expenses remained stable at $9.8 million.
Speaker #5: As of June 30, 2025, we had €70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026.
Speaker #5: With that, I'm turning it back to Jonathan for closing remarks.
Speaker #4: Thank you, Frederic. Turning to slide 28, you can see our new flow for the near and mid-term, which is fully aligned with the strategic refocus I outlined at the beginning of today’s call.
Jonathan Dickinson: Thank you, Frederic. Turning to slide 28, you can see our new flow for the near and midterm, which is fully aligned with the strategic refocus I outlined at the beginning of today's call. For IPH4502, our novel NECTIN-4 ADC phase 1 trial is progressing well, and we expect data in the first half of 2026. While our preclinical R&D continues to build a strong ADC pipeline to fuel our next wave of candidates, as shown by Yannis, lacutamab has secured FDA breakthrough therapy designation supported by long-term follow-up data presented at ASCO. We are preparing for phase 3 protocol submission following our discussion with regulators, as indicated by Sonia. For monalizumab, AstraZeneca's phase 3 PACIFIC-9 trial is fully recruited and remains on track for primary completion in the first half of 2026, with data expected in the second half of 2026.
Speaker #4: For IPH45O2, our novel NextInfo ADC, the Phase One trial is progressing well, and we expect data in the first half of 2026. While our preclinical R&D continues to build a strong ADC pipeline to fuel our next wave of candidates, as shown by Yannis Morel.
Speaker #4: Lacutamab has secured FDA breakthrough therapy designation, supported by long-term follow-up data presented at ASCO. We are preparing the Phase Three protocol submission following our discussion with regulators, as indicated by Sonia.
Speaker #4: And for Monalizumab, AstraZeneca's Phase 3 Pacific Nine trial is fully recruited and remains on track for primary completion in the first half of 2026, with data expected in the second half of 2026.
Speaker #4: Turning to slide 29, in summary, we are excited about the opportunities ahead and confident in our ability to deliver value for patients and shareholders.
Jonathan Dickinson: Turning to slide 29, in summary, we are excited about the opportunities ahead and confident in our ability to deliver value for patients and shareholders. We are concentrating our investment on what we believe are our highest value clinical stage assets, IPH4502, lacutamab, and monalizumab, where we have multiple near-term catalysts, and we will right-size our organization to deliver on these strategic priorities. With $70.4 million in cash at the end of June, we are funded to the end of the third quarter of 2026, providing Innate Pharma the ability to execute on our focused strategic priorities. Thank you for your attention. With that, operator, please open the line for questions.
Speaker #4: We are concentrating our investment on what we believe are our highest value clinical-stage assets: IPH45O2, Lacutamab, and Monalizumab, where we have multiple near-term catalysts. We will right-size our organization to deliver on these strategic priorities.
Speaker #4: With $70.4 million in cash at the end of June, we have funded to the end of the third quarter of 2026, providing Innate with the ability to execute on our focused strategic priorities.
Speaker #4: Thank you for your attention. With that, operator, please open the line for questions.
Speaker #6: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad.
Operator: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again. If you are listening via the webcast, you may submit questions via the Q&A box on your screen. Your first phone question today comes from the line of Dana Greybosch from Leerink Partners. Your line is open.
Speaker #6: If you would like to withdraw your question, simply press *1 again. If you are listening via the webcast, you may submit questions via the Q&A box on your screen.
Speaker #6: Your first phone question today comes from the line of Dana Grebosch from Larink Partners. Your line is open.
Speaker #7: Hey, good morning, guys. You got Bill on for Dana. So thanks for the question. So I guess, what should we take away on the potential of targeting MK cells now that anchors are not included in your prioritization today?
[Analyst 1]: Hey, good morning, guys. You got Bill on for Dana. Thanks for the question. What should we take away on the potential of targeting NK cells now that NK cell engagers are not included in your prioritization today, as well as Eric Vivier sort of leading the company? Thank you.
Speaker #7: As well as Eric Vivier sort of leading the company. Thank you.
Speaker #4: So takeaways from I would like to say from Eric leading the company, maybe that's the place to start off. Eric is leading the company, but he will still play an important role with the company moving forward.
Jonathan Dickinson: Takeaways from, I would like to say, from Eric leaving the company, maybe that's the place to start off. Eric is leaving the company, but he will still play an important role with the company moving forward. He will be an advisor to the R&D Committee of our Board of Directors, and we have an extended research collaboration with his lab. We basically will continue to benefit from any innovation which Eric can bring to the table. Moving back to NK cells and the reading, we are still working on NK cells. It's not our main priority today. We're focusing on what we believe are our highest value clinical assets, IPH4502, lacutamab, and monalizumab.
Speaker #4: He will be an advisor to the R&D committee of our board of directors, and we have an extended research collaboration with his lab. So we basically will continue to benefit from any innovation that Eric can bring to the table.
Speaker #4: Moving back to MK cells and the reading, we are still working on MK cells. It's not our main priority today. We're focusing on what we believe are our highest value clinical assets: IPH45O2, Lacutamab, and Monalizumab.
Speaker #4: We will be basing all future decisions on our MK cell engagers on clinical data and the relevance of that clinical data to markets. We will make the appropriate decisions on those assets when we have that clinical data and establish market relevance based on that data.
Jonathan Dickinson: We will be basing all future decisions on our NK cell engagers on clinical data and the relevance of that clinical data to markets, and we'll make the appropriate decisions on those assets when we have that clinical data and an established market relevance based on that data. It's not the end of NK cells, but it's not our priority today anymore. Can we move to the next question?
Speaker #4: So it's not the end of MK cells, but it's not our priority today anymore. Can we move to the next question? Yeah.
Speaker #6: We'll move on to our next question, and it comes from the line of Swayam Pakula, Remacon from HCW. Your line is open.
Operator: We'll move on to our next question, and it comes from the line of Swayam Pekula, Remicomp from HCW. Your line is open.
Speaker #7: Thank you. Good morning, good afternoon, Jonathan and team. So now that the anchor programs are out, at least as far as your development is concerned, any commentary on where Sanofi is with the assets that they currently are developing?
[Analyst 2]: Thank you. Good morning, or good afternoon, Jonathan and team. Now that the NK cell engager programs are out, at least as far as your development is concerned, any commentary on where Sanofi is with the assets that they currently are developing?
Speaker #4: Absolutely. So, I'd just like to say that it's not the end of the story for MK cells. We're still moving forward and completing the studies with IPH6501.
Jonathan Dickinson: Absolutely. I'd just like to say that it's not the end of the story for NK cells. We're still moving forward and completing the studies with IPH6501. We have a path to explore IPH6101 via investigator-initiated research and an interesting way forward. I wouldn't say it's the end of NK cells. It's just that it's been basically lowered in our current company priorities. From a Sanofi perspective, Sanofi continues to progress the BCMA targeted ANCA, and as I think we've communicated in the past, that's being explored in autoimmunity, in immunology, as part of Sanofi's focus as a company. We expect to have updates from Sanofi on that BCMA program in the near future.
Speaker #4: We have a path to explore IPH61 via investigator-initiated research, and an interesting way forward. So I wouldn't say it's the end of MK cells.
Speaker #4: It's just that it's been basically lowered in our current company priorities. From a Sanofi perspective, Sanofi continues to progress the BCMA-targeted anchor. And as I think we've communicated in the past, that's being explored in autoimmunity and immunology.
Speaker #4: As part of Sanofi's focus as a company, we expect to have updates from Sanofi on that BCMA program in the near future.
Speaker #7: Thanks for that. And then regarding the Phase Three start for Lacutamab, should we still, I assume that unless you have a partner signed up ahead of the start of the study, it'll still, you know, it'll be a wait and watch.
[Analyst 2]: Thanks for that. Regarding the phase 3 start for lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch until you get a partner, or you have enough commitment from investors to go ahead and start that study?
Speaker #7: Till you get a partner, or you have enough commitment from investors to go ahead and start that study?
Speaker #4: So we are actively working with investors at the moment to basically keep options open. We’re continuing discussions with partners, but we also have some very advanced discussions with investors who are very interested in Lacutamab now that we effectively have a de-risked development program to move forward into Phase 3.
Jonathan Dickinson: We are actively working with investors at the moment to basically keep options open. We are continuing discussions with partners, but we also have some very advanced discussions with investors who are very interested in lacutamab now that we effectively have a de-risked development program to move forward into phase 3. We also see interest based now on the increased potential commercial opportunity. This will reinvigorate discussions with partners, and we are also expecting next steps with respect to the finalization of the protocol for the confirmatory phase 3 study, which is also an important step for partners. We continue the discussions with partners, but at this stage, we see it as very important to keep our future options open to either go down the partner route, but with improved deal terms based on the significantly larger potential market opportunity, particularly with the first accelerated approval launch in Sézary syndrome.
Speaker #4: And we also see interest based now on the increased potential commercial opportunity. This will also reinvigorate discussions with partners. Additionally, we are expecting next steps regarding the finalization of the protocol for the confirmatory Phase 3 study, which is also an important step for partners.
Speaker #4: So we continue the discussions with partners. But at this stage, we see it as very important to keep our future options open to either go down the partner route but with improved deal terms based on the significantly larger potential market opportunity, particularly with the first accelerated approval launch in cellular syndrome.
Speaker #4: And so yes, we're keeping the options open with both moving forward with investors and with potential partners.
Jonathan Dickinson: Yes, we're keeping the options open for both moving forward with investors and with potential partners.
Speaker #7: So, last question from me, Jonathan. This is on 45O2. Based on the preclinical data that you have generated so far, what potential indications do you think 45O2 will be effective in?
[Analyst 2]: Last question from me, Jonathan. This is on IPH4502. Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? Since there are numerous NECTIN-4 ADCs in the clinic right now, how differentiated is IPH4502 against those?
Speaker #7: And since there are numerous NextInfo ADCs in the clinic right now, how differentiated are you? Is 4502 against those?
Speaker #4: Yeah. So maybe Sonia can take the first part of that question. Sonia?
Jonathan Dickinson: Yeah. Maybe Sonia can take the first part of that question. Sonia?
Speaker #1: Yes. Can you repeat the question, please?
Sonia Quaratino: Yes. Can you repeat the question, please?
Speaker #7: Yeah. Based on the preclinical data that you have generated today, what indication do you think is where 45O2 could be effective?
[Analyst 2]: Yeah. Based on the preclinical data that you have generated today, you know what indication do you think is where IPH4502 could be effective?
Speaker #1: Right. As I mentioned before, you know, we focus on any indication that expresses NextInfo because we believe that we also can target those indications with a relatively small NextInfo expression.
Sonia Quaratino: Right. As I mentioned before, you know we focus on any indication that expresses NECTIN-4 because we believe that we also can target those indications with a relatively small NECTIN-4 expression. We also very much focus on the urothelial cancer patients who became refractory or resistant to enfortumab vedotin. For these patients, there are no approved drugs. If we have good clinical data in these refractory relapsed patients, we really may have a very fast opportunity for an accelerated market approval in urothelial cancer post-enfortumab vedotin. We are exploring, let's say, the classic path as well as some more defined area for a potential accelerated approval.
Speaker #1: But we also very much focus on the urothelial cancer patients who have become refractory or resistant to PADCEF, and for these patients, there are no approved drugs.
Speaker #1: And you know, if we have clinical, you know, good clinical data in these refractory relapsed patients, we really may have a very fast opportunity for an accelerated market approval in UC post-PADCEF.
Speaker #1: So we are exploring, let's say, the classic path as well as some more defined areas for potential accelerated approval.
Speaker #4: And then, in terms of differentiation, RK, I mean, I think we believe that we'll be able to show differentiation here, particularly versus PADCEF or MMAE-based ADCs.
Jonathan Dickinson: In terms of differentiation, I mean, I think we believe that we'll be able to show differentiation here, particularly versus padcev or MMAE-based ADCs due to the payload and the different resistance and toxicity profile, which we believe we'll be able to show meaningful differences between IPH4502 and MMAE-based ADCs.
Speaker #4: Due to the payload and the different resistance and toxicity profiles, we believe we'll be able to show meaningful differences between IPH45O2 and MMAE-based ADCs.
Speaker #7: Okay. Thank you very much for taking the questions.
[Analyst 2]: Okay, thank you very much for taking my questions.
Speaker #6: Your next question comes from the line of Justin Zelen from BTIG. Your line is open.
Operator: Your next question comes from a line of Justin Zelen from BTIG. Your line is open.
Speaker #7: Thanks for taking our questions. Maybe I'll continue the questioning on 45O2 if you can just give us an update on how enrollment has been progressing here.
[Analyst 1]: Thanks for taking our questions. Maybe I'll continue the questioning on IPH4502. If you can just give us an update on how enrollment has been progressing here. I know you gave an update here on enrollment completion. Just was curious on how you could comment on how enrollment is going today, when we should expect the initial data, if it'll be sometime in the first half of next year, how many patients' worth of data we should expect, and any expectations from a safety or efficacy standpoint from that update.
Speaker #7: I know you gave an update here on enrollment completion just was curious on how you could comment on how enrollment is going today. When we should expect the initial data if it'll be sometime in the first half of next year, how many patients' worth of data we should expect, and any expectations from a safety or efficacy standpoint from that update?
Speaker #4: Sonia, do you want to take it?
Jonathan Dickinson: Sonia, do you want to take it?
Speaker #1: Of course, of course. As mentioned, the enrollment with IPH45 is going extremely well. We always had, let's say, a list of patients to go in at the different dose levels.
Sonia Quaratino: Of course, of course. As mentioned, the enrollment with IPH4502 is going extremely well. We always have, let's say, a list of patients to go in at the different dose level. Also, with the Bayesian design that we have, we have the possibility to have a parallel enrollment in backfill cohorts. We do not have the classic 3+3 design with an extremely limited number of patients, but we can expand different dose levels as we go along. To your question, of course, you know we plan to finish the enrollment in the first quarter of 2026. The data in terms of at least on the first CT scan can only occur, as you can understand, eight weeks or data.
Speaker #1: And also, with the Boeing design that we have, we also have the possibility to have a parallel enrollment in Buckfield cohorts. And so, we do not have the classic three-plus-three design with an extremely limited number of patients, but we can expand different dose levels as we go along.
Speaker #1: To your question, of course, we plan to finish the enrollment in the first quarter of 2026. And, of course, the data in terms of at least on the first CT scan can only occur, as you can understand, eight weeks later.
Speaker #1: Start from the first dosing, and so, you know, it takes another quarter to have the data, the clinical efficacy from the last cohort recruited.
Operator: From the first dosing, it takes, let's say, another quarter to have the clinical efficacy from the last cohort recruited. Having said that, we are going to have probably a pool of data of 50, 60 patients by then.
Speaker #1: Having said that, we are going to have, probably, a pool of data of 50 to 60 patients by then.
Speaker #2: Great, thanks for taking our questions.
Stéphanie Cornen: Great. Thanks for taking our question.
Speaker #3: And there are no further phone questions at this time. I will now turn the call back over to management for any written questions.
Jonathan Dickinson: There are no further phone questions at this time. I will now turn the call back over to management for any written questions.
Speaker #4: Thank you. Yes, we have one question on the line here from Rajan Sharma. So, the first question is: does the new strategic focus mean the Onket assets will not be progressed, irrespective of clinical data, given that 65:1 data are expected in the near term?
Yannis Morel: Thank you. Yes, we have one question on the line here from Rajan Sharma. The first question is, does the new strategic focus mean the ANKET® assets will not be progressed irrespective of clinical data, given that IPH6501 data are expected in the near term?
Speaker #5: So, I think I answered this earlier, but I'll repeat it again. So, IPH65:1 perspective, the study continues, and we expect to have data, I think, as we've communicated previously, towards the end of this year or very early next year.
Sonia Quaratino: I think I answered this earlier, but I'll repeat it again. From an IPH6501 perspective, the study continues, and we expect to have data, I think, as we communicated previously, towards the end of this year or very early next year. We will make any decisions on the next steps for IPH6501 based on that clinical data and the clinical relevance of that data to the marketplace.
Speaker #5: And we will make any decisions on the next steps for IPH65:1 based on that clinical data and the clinical relevance of that data to the marketplace.
Speaker #4: Okay, and so the next question: What is the financial impact of the strategic refocus and headcount reduction? And what proportion of current R&D expense is directed towards IPH45:2 and Lacutamab?
Yannis Morel: Okay. What is the financial impact of the strategic refocus and headcount reduction, and what proportion of current R&D expense are directed toward IPH4502 and lacutamab?
Speaker #5: So, the financial impact we've noted, and we won't be communicating specific numbers on the impact of the financial reductions. We're in a legal process now.
Sonia Quaratino: The financial impact, we've not, and we won't be communicating specific numbers on the impact of the financial reductions. We're in a legal process now, which is a French legal process to reduce the size of the organization, which gives us an obligation not to communicate on certain components. That would fall under that legal framework that we're operating within. We can't provide specific guidance there. In terms of R&D expenses, maybe Frederic would like to comment on the proportion.
Speaker #5: Which is a French legal process to reduce the size of the organization, which gives us an obligation not to communicate on certain components. And that would fall under that legal framework that we're operating within.
Speaker #5: So, we can't provide specific guidance there. In terms of R&D expenses, maybe Frederic would like to comment on the proportion?
Speaker #4: So, the question: what proportion of current R&D expenses are directed towards IPH45:2 and Lacutamab?
Yannis Morel: The question was, what proportion of current R&D expenses are directed toward IPH4502 and lacutamab?
Speaker #5: Yeah, we usually never communicate on the investment that we do in those two in the portfolio. But following up on the comment from Jonathan, we have a significant portion of our external expenditure, which is on those assets.
Frederic Lombard: Yeah, we usually never communicate on the investment that we do in those two in the portfolio. Following up on the comment from Jonathan, we have a significant portion of our external expenditure which are on those assets.
Speaker #4: Okay, so we have another question from Uttama Dengwir. So, with regards to financial visibility, does the estimate for the end of the third quarter of 2026 take into account the impact of the restructuring plan?
Yannis Morel: Okay. We have another question from Oussama Dengue. With regard to financial visibility, does the estimate for the end of the third quarter of 2026 take into account the impact of the restructuring plan?
Speaker #5: The answer to that is yes. So, the restructuring plan is fully embedded into the cash runway, which takes us to the end of Q3 2026.
Sonia Quaratino: The answer to that is yes. The restructuring plan is fully embedded into the cash runway, which takes us to the end of Q3 2026.
Speaker #4: And last question: concerning phase three of Lacutamab, can you provide an initial estimate of the investment requirements if you decide to compile without a partner?
Yannis Morel: Last question, concerning phase 3 of lacutamab, can you provide an initial estimate of the investment requirements if you decide to go into trial without a partner?
Speaker #5: Again, this is something that we would not normally communicate on in terms of the cost. This is a standard phase three study, so I think you can draw your own conclusions.
Sonia Quaratino: Again, this is something that we would not normally communicate on in terms of the cost. This is a standard phase 3 study, so I think you can draw your own conclusions. It's nothing too dissimilar from similar oncology phase 3 trials.
Speaker #5: It's nothing too dissimilar from oncology Phase 3 trials.
Speaker #4: Thank you, Jonathan. There is no further question.
Yannis Morel: Thank you, Jonathan. There's no further question.
Speaker #5: Okay, so thank you for everybody's time and attention, and for your interest in Innate Pharma. We look forward to meeting with you in person in the near future or on one of our next calls.
Sonia Quaratino: Thank you for everybody's time and attention and for your interest in Innate Pharma. We'll look forward to meeting with you in person in the near future or on one of our next calls. Thank you and goodbye.
Speaker #5: Thank you and goodbye.
Speaker #3: This concludes today's conference call. Thank you for your participation. You may now disconnect.
Jonathan Dickinson: This concludes today's conference call. Thank you for your participation. You may now disconnect.
[Analyst 1]: Please wait. The conference will begin shortly.